The Clinical Data Interchange Standards Consortium (CDISC) is a clinical research standards body formed to encourage maximum sharing of information and minimum duplication of efforts.  One of the standards CDISC has created and endorsed is the Operational Data Model (ODM), which facilitates the archive and interchange of the metadata and data for clinical research. ODM is represented in XML format and is designed to collect data from many different sources into one document.

Purpose of This Document

OpenClinica provides and/or consumes CDISC ODM XML representations in its Extract Data and Import Data modules and other parts of the software. This document describes how OpenClinica represents study metadata and data that is stored in its internal database as CDISC ODM XML documents. It assumes a working knowledge of CDISC ODM 1.3 and of OpenClinica, and attempts to describe how each OpenClinica field or element is represented in ODM, and under what conditions. The document is best read when accompanied by the CDISC ODM standard. It is geared towards developers, but is also intended for data managers who want to know more about the capabilities of ODM XML export in OpenClinica. Additionally, parts of this document will find its way into the online documentation, for all end users.

OpenClinicas ODM representation has changed iteratively from version to version of OpenClinica, and the appendix to this document charts these changes since version 2.5 and the addition of the custom extension to the ODM, introduced with OpenClinica 3.0.

Scope of This Document

This document provides a detailed specification of the OpenClinica CDISC ODM XML version 1.3 with OpenClinica Extensions as implemented in the OpenClinica 3.1 and later releases.

Definitions and Acronyms

General Issues

CDISC defines its Operational Data Model, version 1.3, as a vendor neutral, platform independent format for interchange and archive of clinical trials data. The model includes the clinical data along with its associated metadata, administrative data, reference data and audit information. All of the information that needs to be shared among different software systems during the setup, operation, analysis, submission or for long term retention as part of an archive is included in the model.

An XML document must meet certain basic criteria to be considered conformant to the ODM standard. These are briefly discussed below:

Syntatic Constraints

The syntactic constraints defined by the ODM standard are:

  1. The ODM file must be a well-formed XML file. See the XML standard for details.
  2. The ODM file must conform to the XML Namespace standard. See the XML Namespace standard for details.
  3. The ODM file must contain only elements and attributes defined in the ODM standard schema or in a valid vendor extension schema, and must satisfy the rules about element nesting and the formats of attribute values and element bodies.
  4. The ODM file must contain a prolog and a single (top-level) ODM element.
  5. The namespace for version 1.3 of the ODM is http://www.cdisc.org/ns/odm/v1.3.

Currently, the ODM study definition file (available from the View Study page at the URL /DownloadStudyMetadata?studyId=#) does not meet these requirements for the following reasons:

  1. The file generated from the View Study page is only a fragment of XML, and does not contain the initial tag which defines the character set and version, i.e. <?xml version=”1.0″ encoding=”UTF-8″?>.
  2. The file generated does not contain references to any XML Namespaces, including the namespace for version 1.3 of the ODM itself.
  3. The file generated does contain elements defined in the ODM standard schema, but lacks the single top-level ODM element.
  4. The files suffix is txt instead of xml.

OpenClinica ODM Data Import meets the above constraints, but note that OpenClinica parses everything within the ClinicalData element only, and it does not read anything in the Study element, and, as such, cannot import Study metadata at this time.

Entities and Elements

Entities and elements in OpenClinica use the same names as their counterparts in ODM. For example, the ODM definitions for study event and Study Event Definition are valid for the entities of the same name in OpenClinica (see Section 2.6, Entities and Elements, of the ODM specification):

  • A study event is a reusable package of forms usually corresponding to a study data-collection event.
  • A Study Event Definition describes a particular type of study event (mostly by listing the types of forms it can contain).
  • The clinical data of a study will typically have many actual study events corresponding to each StudyEventDef,

Where the usage of these entity names in OpenClinica diverges from the ODM definition, it will be noted in this document.

Clinical Data Keys

The ODM standard uses the concept of Internal Clinical Data Keys to uniquely address clinical data entities within the model. The following table details the key, or combination of entity identifiers, that you would need to uniquely and specifically address a clinical data entity.

Kind of EntityIdentifying Keys (ODM)Identifying Keys (OpenClinica ODM)
StudyStudyOIDSame as ODM
Subjectabove plus SubjectKeySame as ODM
Study Event

above plus StudyEventOID and StudyEventRepeatKey
Same as ODM
Formabove plus FormOID and FormRepeatKeySame as ODM, however repeating forms are not supported so no FormRepeatKey is necessary
Item Groupabove plus ItemGroupOID and ItemGroupRepeatKeySame as ODM
Item

above plus ItemOID
Same as ODM
Annotationkeys for the annotated entity plus SeqNumNot used in OpenClinica

For example, an XPath query to retrieve a specific item data value in an OpenClinica ODM Extract would be of the form:

/odm:ODM/odm:ClinicalData[@StudyOID=’S_P12345_2818′]/odm:SubjectData[@SubjectKey=’SS_101′]/odm:StudyEventData[@StudyEventOID=’SE_INITIALT’ and  @StudyEventRepeatKey=’1′]/odm:FormData[@FormOID=’F_AGEN_V10′]/odm:ItemGroupData[@ItemGroupOID=’IG_AGEN_DOSETABLE-F_AGEN_V10′ and @ItemGroupRepeatKey=’1′]/odm:ItemData[@ItemOID=’I_AGEN_AGENT_NAME’]/@Value

In the image below you can see that the latter half of the XML file (the part  contained in the <ClinicalData> tags) links to specific tables in the OpenClinica database. We then link back to the Study metadata through those OIDs. Internally we dont use OIDs in those tables, but instead the conventional methods of primary keys and foreign keys in the database is good enough. For more on how ODM, OIDs, and Clinical Data Keys are implemented in OpenClinica see the blog post, “Thoughts on Code: OpenClinica and Open Standards with CDISC”.

Data Representations in ODM XML (Extract)

When OpenClinica outputs ODM XML, the five basic XML entities (gt, lt, quot, amp, apos) are escaped using XML Entity notation (For example: “bread” & “butter” => &quot;bread&quot; &amp; &quot;butter&quot;).

Whitespace is represented literally linebreaks and tabs in ItemData values and other fields will be preserved.  Note that, while tabs and carriage returns are limited in the data entry side of the application, (tabs will automatically shift focus from one Item to the next, for example) all spaces and linebreaks are saved to the database, and will export into ODM XML.

Items saved in the database with non-ASCII characters will be extracted to XML entities using their ASCII decimal value equivalents; please see the next section, “OpenClinica Data Representations in ODM XML (Extract)” for an example of this.

Item Data Types

OpenClinica supports a subset of the Item Data Types defined in ODM. The data type mapping is shown below, along with the allowed string pattern used to validate item values for a given data type.  Note that a listing of no definition in the table below means that the data type is not supported in OpenClinica.

Item Data Types

CDISC Item Data TypeOpenClinica Data TypeAllowed Values (Data Import)Representation of Values (Extract)
textSTAny sequence of characters up to the maximum allowed number of characters (currently 4000). If the value is greater than the width is specified in the items width_decimal property (or 255, whichever is less), a discrepancy note will be created but the data will be allowed.
partialDatePDATEA date represented according to the XML schema date datatype, which is based on the ISO8601 standard (YYYY-MM-DD).A date represented according to the XML schema date datatype, which is based on the ISO8601 standard (YYYY-MM-DD).

Partial Dates can be YYYY-MM or YYYY and will be exported as YYYY-MM or YYYY.
textFILE

Files cannot be imported into ODM at this time.
A string representing the file name of the stored file, up to the maximum allowed number of characters (currently 4000).
integerINT-?digit+

If the value is greater than the width specified in the items width_decimal property (or 255, whichever is less), a discrepancy note will be created but the data will be allowed.
floatREAL-?digit+(.digit+)?

If the value is greater than the width is specified in the items width_decimal property (or 255, whichever is less), a discrepancy note will be created but the data will be allowed.

Float values will only be rounded for calculations, based on the decimal specified in the items width_decimal property if it exists. If no width_decimal is provided it will round to the 4th decimal place.  For example, if someone entered a value like 6.987398 into a field that is not a calculation, the number will not be rounded to the 4th decimal place.
dateDATEA date represented according to the XML schema date datatype, which is based on the ISO8601 standard (YYYY-MM-DD).A date represented according to the XML schema date datatype, which is based on the ISO8601 standard (YYYY-MM-DD).
timeNo definition
datetimeNo definition
stringNo definition
booleanNo definition
doubleNo definition
hexBinaryNo definition
base64FloatNo definition
partialTimeNo definition
partialDatetimeNo definition
durationDatetimeNo definition
intervalDatetimeNo definition
incompleteDatetimeNo definition
URINo definition

Mapping of OpenClinica Elements to ODM

CDISC ODMOpenClinica Data Schema (table.column_name)OpenClinica CRF SpreadsheetExample Values (Comments)
ODM
FileOIDdataset.name-D-creationDateTimeIntervention_DatasetD20100924143323+0300
CreationDateTime2010-09-24T14:33:23+03:00
FileTypeSnapshot (generated automatically)
ODM Version1.3
xsi:schemaLocation

http://www.cdisc.org/ns/odm/v1.3 OpenClinica-ODM1-3-0-OC2-0.xsd
Study
OIDstudy.oc_oidS_DEMO123
StudyNamestudy.nameDemonstration Study
StudyDescriptionstudy.summaryThis study is used for demonstrational purposes
ProtocolNamestudy.unique_identifierDemo123
MeasurementUnit
OIDmeasurement_unit.oc_oidMU_HG
Namemeasurement_unit.nameUNITSHg
Symbol
TranslatedText

item.unitsUNITSHg
MetaDataVersion
OIDdataset.odm_metadataversion_oidv1.0.0 (defined at dataset creation time)
Namedataset.odm_metadataversion_nameMetaDataVersion_v1.0.0
StudyEventRef
StudyEventOIDstudy_event_definition.oc_oidSystematically generated when a study event definition is created.  Refer to section 2.4.1
OrderNumberstudy_event.sample_ordinalThe order the event definitions appear in the system.  These values can be rearranged by certain users.
Mandatoryevent_definition_crf.required_crfIf at least one CRF in the event definition is set to Required, the event itself becomes required.
StudyEventDef
OIDstudy_event_definition.oc_oidSystematically generated when a study event definition is created.  Refer to section 2.4.1
Namestudy_event_definition.nameInitial Visit
Repeatingstudy_event_definition.repeatingYes, No
Typestudy_event_definition.typeScheduled, Unscheduled, Common.  The values conform to CDISC terms.
FormRef
FormOIDcrf_version.oc_oidF_DEMOGRAPHICS_1
Mandatoryevent_defintion_crf.required_crfYes, No
FormDef
OIDcrf_version.oc_oidF_DEMOGRAPHICS_1
Namecrf.name + crf_version.nameCRF_NAME + VERSIONDemographics-Dynamics - 1
RepeatingNo (generated automatically)
ItemGroupRef
ItemGroupOIDitem_group.oc_oidIG_DEMOG_UNGROUPED
MandatorySame as ItemRef – MandatoryYes, No
OpenClinica:FormDetails
FormOIDcrf_version.oc_oidF_DEMOG_1
ParentFormOIDcrf.nameCRF_NAMEDEMOG
VersionDescriptioncrf_version.descriptionVERSION_DESCRIPTIONThis CRF version contains 2 additional items
RevisionNotescrf_version.revision_notesREVISION_NOTESI revised this CRF and created this new version.
OpenClinica:SectionDetails
OpenClinica:Section
SectionLabelsection.labelSECTION_LABEL
SectionTitlesection.titleSECTION_TITLE
SectionSubtitlesection.subtitleSUBTITLE
SectionInstructionssection.instructionsINSTRUCTIONS
SectionPageNumbersection.page_number_labelPAGE_NUMBER
OpenClinica:PresentInEventDefinition
StudyEventOIDstudy_event_definition.oc_oidSystematically generated when a study event definition is created. Refer to section 2.4.1
IsDefaultVersionevent_definition_crf.default_version_idTrue, False
PasswordRequiredevent_definition_crf.electronic_signatureTrue, False
DoubleDataEntryevent_definition_crf.double_entryTrue, False
HideCRFevent_definition_crf.hide_crfTrue, False
SourceDataVerificationevent_definition_crf.source_data_verification100% Required, Partial Required, Not Required, Not Applicable
ItemGroupDef
OIDitem_group.oc_oidIG_DEMOG_UNGROUPED
Nameitem_group.nameGROUP_LABELUngrouped (if the items are ungrouped)
Repeating

item_group_metadata.repeating_groupGROUP_LAYOUTYes, No
Commentitem_group_metadata.headerGROUP_HEADER
SASDatasetNameUNGRO044 (generated automatically; take the item_group.name, switch to all caps, and truncate to eight characters, adding integers and alpha characters to the end to make unique)
ItemRef
ItemOIDitem.oc_oidI_THAP_BLOODPRODTYP
OrderNumberitem_form_metadata.ordinal1, 2, 3, etc.
Mandatoryitem_form_metadata.requiredREQUIREDYes, No
OpenClinicaItemGroupDetails
ItemGroupOIDitem_group.oc_oidIG_DEMOG_UNGROUPED
OpenClinica:PresentInForm
FormOIDcrf_version.oc_oid
ShowGroupitem_group_metadata.show_groupGROUP_DISPLAY_STATUSHIDE, SHOW
OpenClinica:ItemGroupRepeat
RepeatNumberitem_group_metadata.repeat_numberGROUP_REPEAT_NUMBER
RepeatMaxitem_group_metadata.repeat_maxGROUP_REPEAT_MAX
ItemDef
OIDitem.oc_oidI_THAP_BLOODPRODTYP
Nameitem.nameITEM_NAMEBloodProdTyp
DataTypeitem_data_type.nameDATA_TYPESText, float, integer, etc.
Lengthitem_form_metadata.width_decimalWIDTH_DECIMAL*(For ODM ‘float’ data types, the length is based on the ‘width’ parameter specified in the WIDTH_DECIMAL field in the spreadsheet (if it is provided).



For other data types, length is calculated based on the maximum length of all the values for the item.)
SignificantDigitsitem_form_metadata.width_decimalWIDTH_DECIMAL*(For ODM ‘float’ data types, the SignificantDigits is based on the ‘decimal’ parameter specified in the WIDTH_DECIMAL field in the spreadsheet.



For other data types, SignificantDigits is not used.)
SASFieldNameBlood301 (again, generated from the item.name, but truncated to eight characters with an integer at the end to enforce uniqueness)
Commentitem.description
DESCRIPTION_LABEL
OpenClinica:FormOIDscrf_version.oc_oid
F_THAP_V10 (comma-separated list of CRF version OIDs where the item is found)
Question
OpenClinica:QuestionNumberitem_form_metadata.question_numberQUESTION_NUMBER
TranslatedTextitem_form_metadata.header + item_form_metadata.left_item_text + item_form_metadata.right_item_textLEFT_ITEM_TEXT

RIGHT_ITEM_TEXT

HEADER

SUB_HEADER
“Amount of blood product (ml)”
MeasurementUnitRef
MeasurementUnitOIDmeasurement_unit.oc_oidSystematically generated when a CRF Version is uploaded containing an item with a value in the UNITS cell.
CodeListRef
CodeListOIDresponse_set.response_set_idCL_233 (OID generated automatically by adding the prefix ‘CL_’ to the primary key)
RangeCheck
Comparatoritem_form_metadata.regexp (if "func:")VALIDATIONLE, GE, EQ, etc.
SoftHardSoft, Hard (based on study parameter values governing discrepancy note generation)
CheckValueItem_form_metadata – the value in the function. For example, “95” if the check is for greater than 95,VALIDATION100
ErrorMessage
TranslatedTextitem_form_metadata.regexp_error_msg (if "func:")VALIDATION_ERROR_MESSAGEPlease specify a value between 0 and 100
OpenClinica:ItemDetails
ItemOIDitem.oc_oid
Systematically generated when a CRF Version is uploaded to OpenClinica
OpenClinica:PresentInForm
FormOIDcrf_version.oc_oid
ParentItemOIDitem.oc_oid
ColumnNumberitem_form_metadata.column_numberCOLUMN_NUMBER1, 2, 3 etc.
PageNumberitem_form_metadata.page_numberPAGE_NUMBER1, 2, 3 etc.
PHIitem.phi_statusPHI1, 0
ShowItemitem_form_metadata.show_itemITEM_DISPLAY_STATUSSHOW, HIDE
OrderInFormitem_form_metadata.ordinalThe items order shown in UI from view crf page.
OpenClinica:LeftItemTextitem_form_metadata.left_item_textLEFT_ITEM_TEXTHeight
OpenClinica:RightItemTextitem_form_metadata.right_item_textRIGHT_ITEM_TEXTHeight
OpenClinica:ItemHeaderitem_form_metadata.headerHEADERThis field captures Height
OpenClinica:ItemSubHeaderitem_form_metadata.subheaderSUB_HEADERPlease provide the Height in inches.
OpenClinica:SectionLabelsection.labelSECTION_LABEL
OpenClinica:ItemResponseresponse_type.nameRESPONSE_TYPE
CodeList
OIDresponse_set.response_set_idCL_233 (OID generated automatically by adding the prefix ‘CL_’ to the primary key)
Nameresponse_set.labelRESPONSE_LABELyn
DataTypeitem_data_type.nameDATA_TYPESText, float, integer, etc.
SASFormatName
$YN54X (generated, with Name in all caps with a ‘$ and an extra suffix to be unique)
CodeListItem
CodedValue

response_set.options_valuesREPONSE_VALUES_OR_CALCULATIONS1, 2, 3, etc.
Decode
TranslatedTextresponse_set.options_textRESPONSE_OPTIONS_TEXTYes, No, etc.
OpenClinica:MultiSelectList
OpenClinica:IDresponse_set.response_set_id
MSL_54 (generate an OID on the fly by adding the prefix ‘MSL_’ to the iprimary key)
OpenClinica:Nameresponse_set.labelRESPONSE_LABELOptionsList
OpenClinica:DataTyperesponse_type.nametext, (the DataType value is always ‘text’)
OpenClinica:ActualDataTyperesponse_type.nameDATA_TYPEtext, float, integer
OpenClinica:MultiSelectListItem
OpenClinica:CodedOptionValueresponse_set.options_valuesRESPONSE_VALUES_OR_CALCULATIONS1, 2, 3, etc.
OpenClinica:StudyGroupClassList
OpenClinica:IDstudy_group_class.study_group_class_idSGC_1 (‘SGC_’ prefix automatically appended)
OpenClinica:Namestudy_group_class.nameAge Classification
OpenClinica:Statusstatus.nameAvailable
OpenClinica:Type

group_class_types.nameArm, Demographic, etc.
OpenClinica:SubjectAssignment

study_group_class.subject_assignmentOptional
OpenClinica:StudyGroupItem
OpenClinica:Namestudy_group.nameYoung Adult
OpenClinica:Descriptionstudy_group.description12-18
OpenClinica:StudyDetails
StudyOIDstudy.oc_oid
SiteNamestudy.namePresent only when extracting site level ODM.
ParentStudyNamestudy.nameGives the name of study which this site is part of. Tag is present only when the ODM is retrieved at site level.
OpenClinica:StudyDescriptionStatus
OfficialTitlestudy.official_title
SecondaryIDsstudy.secondary_identifier
DateCreatedstudy.date_created2011-01-01
StartDatestudy.date_planned_start2011-01-01
StudyCompletionDatestudy.date_planned_end2011-12-31
OpenClinica:StudySystemStatus

study.status_idAvailable, Pending, Locked, Frozen
OpenClinica:PrincipalInvestigatorstudy.principal_investigatorJohn Smith
OpenClinica:DetailedDescriptionstudy.protocol_descriptionThis is a demonstration study.
OpenClinica:Sponsorstudy.sponsorDrug Company A
OpenClinica:Collaboratorsstudy.collaboratorsThis can be a list of different organizations
OpenClinica:StudyPhasestudy.phaseN/A, Phase I, Phase I/Phase II, Phase II, Phase II/Phase III, Phase III, Phase III/Phase IV, Phase IV
OpenClinica:ProtocolTypestudy.protocol_typeInterventional, Observational
OpenClinica:ProtocolVerificationDatestudy.protocol_date_verification2011-01-01
OpenClinica:Purposestudy.purposeTreatment, Prevention, Diagnosis, Supportive Care, Screening, Health Services Research, Basic Science, Other
OpenClinica:Allocationstudy.allocationRandomized Clinical Trial, Non-Randomized Clinical Trial, N/A
OpenClinica:Maskingstudy.maskingOpen, Single Blind, Double Blind
OpenClinica:Controlstudy.control
OpenClinica:InverventionModelstudy.interventions
OpenClinica:ConditionsAndEligibilitystudy.eligibility
OpenClinica:Conditionsstudy.conditions
OpenClinica:Keywordsstudy.keywords
OpenClinica:EligibilityCriteria
OpenClinica:Sexstudy.gender
OpenClinica:Age
MinimumAgestudy.age_min
MaximumAgestudy.age_max
OpenClinica:HealthyVolunteersAcceptedstudy.healthy_volunteers
OpenClinica:ExpectedTotalEnrollmentstudy.expected_total_enrollment
OpenClinica:FaciltyInformation
OpenClinica:FacilityNamestudy.facility_name
OpenClinica:FacilityCitystudy.facility_city
OpenClinica:FacilityStatestudy.facility_state
OpenClinica:PostalCodestudy.facility_zip
OpenClinica:FacilityCountrystudy.facility_country
OpenClinica:FacilityContactNamestudy.facility_contact_name
OpenClinica:FacilityContactPhonestudy.facility_contact_phone
OpenClinica:FacilityContactEmailstudy.facility_contact_email
OpenClinica:RelatedInformation
OpenClinica:MEDLINEIdentifierstudy.medline_identifier
OpenClinica:ResultsReferencestudy.results_reference
OpenClinica:URLReferencestudy.url
OpenClinica:URLDescriptionstudy.url_description
OpenClinica:StudyParameterConfiguration
OpenClinica:StudyParameterListRef
StudyParameterListID

study_parameter.name
Valuestudy_parameter_value.value
OpenClincia:StudyParameterListItem
CodedParameterValuestudy_parameter.name
RuleImportRules are a separate vendor extensions from the OpenClinica: namespace.
RuleAssignment
RuleRef
OIDrule.oc_oid
ShowActionrule_action.action_type
ifExpressionEvaluatesrule_action.expression_evaluates_to
HideActionrule_action.action_type
ifExpressionEvaluates

rule_action.expression_evaluates_to
EmailActionrule_action.action_type
ifExpressionEvaluatesrule_action.expression_evaluates_toTRUE or FALSE
DiscrepancyNoteActionrule_action.action_type
ifExpressionEvaluatesrule_action.expression_evaluates_toTRUE or FALSE
InsertActionrule_action.action_type
ifExpressionEvaluatesrule_action.expression_evaluates_toTRUE or FALSE
Run
AdministrativeEditingrule_action.administrative_data_entryTRUE or FALSE
InitialDataEntryrule_action.initial_data_entryTRUE or FALSE
DoubleDataEntryrule_action.double_data_entryTRUE or FALSE
Batchrule_action.batchTRUE or FALSE
Messagerule_action.messageThe values do not match, please verify the data provided.
DestinationProperty
OIDrule_action_property.oc_oidThis will be an OID. If the item is part of the same group, then the user should
RuleDef
OID

rule.oc_oidAll capital letters or integers. This is user defined
Namerule.name
Descriptionrule.descriptionDescribe the rule to put it into a context you will recognize.
Expressionrule_expression.value
The expression is used to validate data values to then decide if an action should be taken.
User
OIDGenerated automatically by taking the value in user_account.user_id and appending USR_ to the front
FullNameuser.user_namejsmith
ListNameuser.first_nameJohn
LastNameuser.last_nameSmith
Organizationuser.institutional_affiliationEnterprise Organization
ClinicalData
StudyOIDstudy.oc_oidS_DEMO123
MetaDataVersionOIDdataset.odm_metadataversion_oidv1.0.0
SubjectData
SubjectKeystudy_subject.oc_oidSS_101
OpenClinica:StudySubjectIdstudy_subject.labelSS_101
OpenClinica:UniqueIdentifiersubject.unique_identifier101
OpenClinica:Statusstatus.nameavailable
OpenClinica:SecondaryIdstudy_subject.secondary_label
OpenClinica:YearOfBirthsubject.date_of_birth2001 (depends on the study parameters; if study does not require date of birth or records full date of birth, this is not included)
OpenClinica:DateOfBirthsubject.date_of_birth2001-01-01 (depends on the study parameters; if subject is year only or if date of dirth is not recorded, this is not included)
OpenClinica:Sexsubject.genderm, f
StudyEventData
StudyEventOIDstudy_event_definition.oc_oidSE_OBSERVAT
StudyEventRepeatKey
1, 2, 3, etc. (optional, not included if not repeating)
OpenClinica:StudyEventLocationstudy_event.locationBoston, MA
OpenClinica:StartDate
study_event.date_start2010-10-10
OpenClinica:EndDateOpenClinica:EndDatestudy_event.date_end
2010-12-31 (optional, not included if left blank)
OpenClinica:Statusstatus.namesigned, available, etc.
OpenClinica:SubjectAgeAtEvent13 (calculated automatically
FormData
FormOIDcrf_version.oc_oid
OpenClinica:Versioncrf_version.name
OpenClinica:InterviewerNameevent_crf.interviewer_name
OpenClinica:InterviewDateevent_crf.date_interviewed
OpenClinica:Statusstatus.name
ItemGroupData
ItemGroupOID
TransactionType
ItemGroupRepeatKey
ItemData
ItemOID

item.oc_oidI_GROU_TC_ADV_PRIMARY_03
Valueitem_data.valueYes (only generated if the item is null)
IsNull(only generated if the item is null)
OpenClinica:ReasonForNullitem_data.value
OpenClinica:AuditLogs
IDSystem generated ID taken from the audit_log_event.audit_id and appending AL_ to the beginning
UserIDReferences the value for User OID
DateTimeStampaudit_log_event.audit_date1000-11-16T10:15:37
AuditTypeaudit_log_event_type.nameThe audit log type
OldValue

audit_log_event.old_value
NewValueaudit_log_event.new value
OpenClinica:DiscrepancyNotes
EntityIDItem OID, Event OID, Study Subject OID
OpenClinica:DiscrepancyNote
IDSystem generated by appending DN_ to the value from discrepancy_note.discrepancy_note_id
Status
New, Updated, Resolution Proposed, Closed, Not Applicable
NoteType

Query, Failed Validation Check, Reason for Change, Annotation
DateUpdated
NumberOfChildrenAdds up the number of child notes that exist in the thread.
OpenClinica:ChildNote
StatusNew, Updated, Resolution Proposed, Closed, Not Applicable
DateCreated
OpenClinica:DescriptionValue outside of range
OpenClinica:DetailedNote
This value was outside of the range that is accepted. Please follow up with this subject and see if they should be enrolled or not.
UserRef
UserOID
OpenClinica:SubjectGroupData
OpenClinica:StudyGroupClassIDSGC_1
OpenClinica:StudyGroupClassNameAge Classification
OpenClinica:StudyGroupNameYoung Adult